CABOT 003820

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-06-30 for CABOT 003820 manufactured by Cabot Medical.

Event Text Entries

[21246987] A cabot irrigation system used on a laprascopic gallbladder was not functioning properly. The cabot pump read pressure of 400-500 but irrigation flow was slow. Examination of the o-rings revealed to be lightly flaked and shredded. Bits of red rubber were noted in the nezhat suction/irrigator tip thru which the irrigation flows. Company representative had traded out the o-rings and these were not the company's product. Device not labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination, other. Results of evaluation: foreign material contamination, material degradation/deterioration. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service, use of all similar devices stopped temporarily. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3669
• MDR Report Key: 3669
• Date Received: 1992-06-30
• Date of Report: 1992-06-15
• Date of Event: 1992-06-04
• Date Facility Aware: 1992-06-04
• Report Date: 1992-06-15
• Date Reported to Mfgr: 1992-06-04
• Date Added to Maude: 1993-04-30
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CABOT
• Generic Name: SEAL FOR ABBOTT BOTTLE CAP-O-RING
• Product Code: KPL
• Date Received: 1992-06-30
• Catalog Number: 003820
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3415
• Manufacturer: CABOT MEDICAL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-06-30